PARENT-DETERMINED ORAL MONTELUKAST THERAPY FOR PRESCHOOL WHEEZE (Wheeze And Intermittent Treatment: WAIT) Study Protocol Version 7 Signed by Professor Jonathan Grigg Chief Investigator th Dated: 24 June 2011 WAIT Trial_ Protocol_v7_24th June 2011 Page 1 of 58 Protocol as approved by National Research Ethics Service Reference 09/H1102/110 Date 23rd November 2009 Full title of the protocol: Parent-determined oral montelukast therapy for preschool wheeze with stratification for arachidonate-5-lipoxygenase (ALOX5) promoter genotype. Short title (Acronym): Wheeze And Intermittent Treatment: WAIT MREC Reference Number: 09/H1102/110 – 23rd November 2009 MHRA Reference Number: 21313/0024/01-0001 – 7th January 2010 EudraCT Number: 2009-015626-11 ClinicalTrials.gov: NCT01142505 NIHR CSP Number: 35170 Sponsor: Queen Mary University London Approval Ref 006539 QM Representative of the sponsor: Mr Gerry Leonard (Joint Research Office) 5 Walden Street Whitechapel, London, E1 2EF Phone: 0207 882 7260 Email:
[email protected] Funder: National Institute of Health Research/ Medical Research Council Efficacy and Mechanism Evaluation Programme Alpha House, University of Southampton, Science Park, Southampton, SO16 7NS, Tel: 02380594303 Fax: 02380595939 Post Award Manager: Dr Jane Sinclair EME Programme Manager
[email protected] All Trusts and organisations: Barts and The London School of Medicine and Dentistry Centre for Paediatrics Institute of Cell and Molecular Science The Blizard Building 4 Newark Street, London E1 2AT, UK Centre for